The Ministry of Social Affairs and Health and Women’s Rights has just announced, in a press release, the occurrence of a serious accident as part of a Phase 1 clinical trial, carried out on a Drug under development by a European laboratory. This accident caused the hospitalization at the Rennes University Hospital of 6 volunteers participating in this trial. One of them, in resuscitation, is in a state of death. The 5 others, in serious condition, are followed up in the neurology department.
This trial is being conducted by Biotrial, a private laboratory in Rennes specializing in the performance of clinical trials in healthy volunteers, with the aim of evaluating the safety of use, the tolerance rancid, pharmacological profiles of new molecules. This research center is accredited by the Ministry of Health.
Contrary to what had been said at the beginning of the day, the test did not relate to a product derived from cannabis but a molecule which acts on the natural systems which make it possible to fight against pain, that is, what is called the endocannabinoid system.
The trial which is now in question planned to include 128 healthy volunteers, men and women, aged between 18 and 55 years old. To date, 90 people have been administered this molecule in varying doses. Others received a placebo. The laboratory immediately put an end to this test and recalled the volunteers who took part in it. The National Medicines and Health Products Safety Agency (ANSM) has decided to carry out a technical inspection on the site where these clinical trials are carried out.
The Minister of Social Affairs and Health has seized the General Inspectorate of Social Affairs (IGAS) and will visit the site this afternoon.
What is a phase 1 therapeutic trial?
When the research objective is to test a new drug, the term usually used is that of therapeutic testing. The aim of this trial is to develop a new treatment.
According to Inserm, there are about a thousand therapeutic trials in progress in France, whose promoters (instigators of research) are sometimes pharmaceutical industries, sometimes public research organizations.
The molecules selected in the “preclinical phase” are tested in the laboratory in order to assess their main effects and their toxicity. Then come the “therapeutic phases”.
Phase 1, as is the case for the molecule tested in Rennes, makes it possible to study the evolution of the molecule in the organism as a function of time and to analyze the toxicity on the human being. This phase is carried out on a small number of voluntary and non-sick people.
In phase 2, the molecule is tested on a small number of patients in order to find the smallest effective dose.
In phase 3, researchers compare the benefits of this new molecule compared to existing ones (when they exist) or compared to a placebo.
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